PRICE PER TEST $8.99 TEST BinaxNOW COVID-19 Ag Card For Rapid Detection of SARS-CoV-2 | FDA EUA | IVD Use | RX Only The BinaxNOW COVID-19 Ag Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Negative results should be treated as presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. The BinaxNOW COVID-19 Ag Card is intended for use by medical professionals or trained operators who are proficient in performing rapid lateral flow tests. BinaxNOW COVID-19 Ag Card is only for use under the Food and Drug Administration's EUA. Kit Details Test Card: 40 cards with test strips Extraction Reagent: bottle containing 7.5 mL of extraction reagent Nasal swabs: 40 sterile, single use specimen sampling swabs Positive Control Swab: 1 each â??individually wrapped for single use Negative Control Swab: 1 each â??individually wrapped for single use Documentation: Product Insert, Procedure Card Performance Data Sensitivity: 97.1% Specificity: 98.5%
CLIA Waived Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests. This test is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The CLIA Waived COVID-19 IgG/IgM Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma. The test is for professional use only. Indication: Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, or plasma (sodium EDTA). Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories. About Test Device EUA Authorized CE Mark Test does NOT give positive or negative result for COVID-19 virus. This is an antibody test, it only indicates past or recent infection. Read Results in 15 Minutes 9 Month Expiration from Date of Manufacture Contents 20 Test Devices 20 Disposable Pipettes 20 Alcohol Prep Pads Sterile Safety Lancets Buffer Package Insert
The CareStart COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Lateral flow assay Detect SARS-CoV-2 nucleocapsid protein antigen Rapid results within 10-15 minutes Intended at POC setting (i.e., in patient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation For use under the Emergency Use Authorization (EUA) only For in vitro diagnostic use only For prescription use only For use with direct anterior nasal and nasopharyngeal swab specimens Clinical Performance 93.75% PPAa and 99.32% NPAb when used with nasopharyngeal swab 87.18% PPAa and 100% NPAb when used with anterior nasal swab
Master Carton - Contains 625 Tests For International Sale Only - Call for Pricing The COVID-19 IgG/IgM Rapid Test Device is an in vitro Immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma. The test is for professional use only. Indication: Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, or plasma (sodium EDTA). Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. About Test Device Gives Positive or Negative Result for COVID-19 IgM/IgG antibodies Read Results in 15 Minutes Contents of each box 25 Test Devices 25 Disposable Pipettes 25 Alcohol Prep Pads Sterile Safety Lancets Buffer Package Insert
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